Safety, blood levels and effects of N,N-dimethyltryptamine [DMT (SPL026)] in healthy participants that have taken psychedelic substances before (Part A) and in healthy participants with little to no psychedelic experience (Part B)
Open-label, crossover Phase I study (target n=30, actual enrolment 14) assessing safety, blood levels and effects of SPL026 (DMT fumarate) given IM and IV in healthy psychedelic-experienced (Part A) and little/no-experience (Part B) participants.
Details
This open-label crossover Phase I trial assessed single IM and IV doses of SPL026 (DMT fumarate) in healthy volunteers; Part A (psychedelic‑experienced) received IM 20 mg then IV 27.5 mg in a crossover, and Part B (little/no experience) received doses/routes informed by Part A.
Primary outcomes were safety and tolerability (AEs, labs, vitals) with PK sampling (IV PK to 2 h, IM PK to 4 h) and multiple PD measures including WEMWBS, STAI, MEQ, EDI, EBI and CEQ; follow-up assessments occurred up to 15 days post-second dosing session.